Monetary Fines for Failing to Post Results on Clinicaltrials.gov
​[Thursday, September 27, 2018]

There has been a lot of criticism over the years of both FDA and NIH for not enforcing the laws for reporting clinical trial results on clinicaltrials.gov. Last week FDA announced a process for penalizing companies and individuals under the same law. It has been more than 10 years since the Food and Drug Administration Amendments Act of 2007 (FDAAA) required that the sponsors of clinical trials register their trials on clinicaltrials.gov and post results of the studies within 1 year of the trial completion or face stiff monetary penalties. While the requirement for registering clinical trials has a very high compliance rate due to FDA asking for a certificate of registration (Form 3674) to accompany all applications, the laws were never enforced for posting results. First, there was confusion about who has the authority to enforce the law. Clinical trials are not regulated by NIH but NIH maintains the clinicaltrials.gov website. FDA regulates the clinical trials but did not have jurisdiction over clinicaltrials.gov website. Now, FDA will start enforcing the laws governing clinicaltrials.gov reporting of results. Under the new process, FDA will collect evidence of compliance with clinicaltrials.gov posting during its GCP inspections. FDA’s GCP inspections are mostly conducted at the time of market approval applications for drugs, biologics or medical devices, hence by the time such inspections happen the clinical trials had been completed and results had been already submitted to the FDA. FDA could also rely on complaints received for non-reporting of results. If a company is found to be in violation of the reporting requirements, it would be sent a Preliminary Notice of Noncompliance (Pre-Notice) Letter and given 30 days to correct the violation. If the company does not address the violation in 30 days, FDA will send a new Notice of Noncompliance and give another 30 days to respond. If the violations are still not addressed, FDA will initiate the monetary penalty process by filing a complaint with FDA’s Division of Dockets Management. The company will be given an opportunity to have a hearing to explain its position and reasons for non-compliance. At the hearing or around that time, the company will be given an opportunity to settle the case with FDA. The process seems to give companies many opportunities to correct the error of reporting and will only penalize companies that are repeat and intentional violators. Although it may seem to give a pass to those who intentionally violate the rules and rectify when caught, the process seems balanced and not overtly onerous on the violators or FDA. This seems like a good start. Now we have wait and see how well it is enforced.